Rhomboid Intercostal and Subserratus Plane Block

NCT04085263 | Completed

• 1 other identifier: 33206/07/19
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy . All the patients will receive general anesthesia. The patients will be randomly allocated into one of the following two groups;- - Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane. \- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane. The primary outcome measure will be the total dose of morphine consumed in the first 24 h after surgery and the secondary outcome will be the postoperative pain score.

Conditions

Postoperative Pain; Regional Anesthesia Morbidity

Keywords

Radical Mastectomy; Postoperative pain; Morphine consumption; subserratus plane block

Outcome Measures

Primary Outcomes (1)

• The postoperative morphine consumprtion

  3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg

  The first 24 hours postoperatively

Secondary Outcomes (1)

• The postoperative pain score

  The first 24 hours postoperatively

Study Arms (2)

Control group

SHAM COMPARATOR

The patients in this group will receive sham rhomboid intercostal and subserratus plane.

Procedure: Control group

Rhomboid intercostal and subserratus plane block group

EXPERIMENTAL

The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

Procedure: Rhomboid intercostal and subserratus plane block group

Interventions

Control group PROCEDURE

The patients in this group will receive sham rhomboid intercostal and subserratus plane.

Also known as: Sham block group

Control group

Rhomboid intercostal and subserratus plane block group PROCEDURE

The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

Also known as: Experimental group

Rhomboid intercostal and subserratus plane block group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• Aged 40-75 years
• ASA class I-II
• Presented for elective radical mastectomy.

You may not qualify if:

• Patients refused to participate.
• Patients with known or suspected allergy to the used medication.
• Patients with preoperative chronic pain
• Patients received preoperative opioids or gabapentoids.
• Patients with major cardiac, renal, respiratory, or hepatic disease.
• Patients with potential risk of coagulopathy
• Uncooperative patients.
• Obese patients with BMI \>36

Sponsors & Collaborators

• Tanta University: lead
• Dr. Mohamed shebl Abdelghany: collaborator

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be kept blind through the use of sham block in the control group. Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study. The investigators will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective study

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: September 1, 2019
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)